Orphan obinutuzumab outperforms Rituxan in CLL trial

In Clinical Development by Tim Peplow

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Rituxan may hold the fort as one of Roche’s top-selling drugs, but you’ll know that the antibody loses patent protection in Europe later this year. Naturally, Roche will be looking for a replacement – and they may well have found one in obinutuzumab. The Swiss-based company has said that phase III trials of obinutuzumab showed the experimental drug to actually outperform it’s elder by delaying disease progression longer than Rituxan in people with chronic lymphocytic leukaemia (CLL).

The phase III trial showed obinutuzumab, also known as GA101, plus chlorambucil was superior to Rituxan plus chlorambucil in helping people with previously untreated CLL live longer without their disease worsening. Roche will be releasing more data on the trial, including how much better obinutuzumab performed than Rituxan, at a meeting in December.

Obinutuzumab has orphan drug status in the EU and the FDA for the treatment of chronic lymphocytic leukaemia. The drug is significant because it is the first type II anti-CD20 medicine that is glycoengineered. The modification of sugar molecules in GA101 allows the antibody to act not only as an immunotherapy but also induce direct cell death. Obinutuzumab has been granted an FDA Breakthrough Therapy Designation and a Priority Review in CLL – meaning a decision on whether the drug can be sold on the market is due by the end of the year.

See where Rituxan appears in the Top 10 Biggest Selling Orphan Drugs in 2018

Read more at Bloomberg >

Will obinutuzumab usurp Rituxan’s position as a blockbuster drug? What do you think? Join our discussion on LinkedIn, or leave a comment below. Want more from Total Orphan Drugs? Sign up to our newsletter – it doesn’t cost anything and only takes a minute.

Read about the World Orphan Drug Congress Europe 2013, 14-15 November 2013, Geneva.